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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Tube Housing, X-Ray, Diagnostic
510(k) Number K921316
Device Name MG-1001 TUBE HOUSING ASSEMBLY
Applicant
Magma Corp.
P.O. Box 1263
Teaneck,  NJ  07666
Applicant Contact MICHAEL RINGART
Correspondent
Magma Corp.
P.O. Box 1263
Teaneck,  NJ  07666
Correspondent Contact MICHAEL RINGART
Regulation Number892.1760
Classification Product Code
ITY  
Date Received03/17/1992
Decision Date 06/22/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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